Special Requirements and Exemptions for Enclosed Radiography Systems

Section 350 Section 350.3050  Special Requirements and Exemptions for Enclosed Radiography Systems a)         Except as exempted by subsection (c) of this Section, the following additional requirements apply to enclosed radiography systems, including systems used in shielded-room radiography.  Enclosed radiography systems (including cabinet systems) that are designed to allow admittance of individuals shall be designed and constructed so that: 1)         All requirements of this Part and of 32 Ill. Adm. Code 340.310(a) and 340.320 are complied with; 2)         Each door fastening mechanism will allow the door to be opened from the inside at all times; 3)         Visible and audible alarms are installed and are activated immediately prior to each initiation of an exposure; and 4)         A reliable interlock or other mechanism is installed at each means of access to the enclosure which will preclude access to an area of radiation hazard either by preventing entry or by automatically reducing the hazard. b)         Each system for enclosed radiography specified in subsection (a) of this Section shall be evaluated initially by the licensee or registrant and at intervals not to exceed 1 year to assure compliance with the requirements of this Part and 32 Ill. Adm. Code 340.310(a) and 340.320.  Records of these evaluations shall be maintained for inspection by the Agency for a period of 5 years after the evaluation. c)         Cabinet x-ray systems designed to exclude individuals are exempt from the requirements of this Part except that: 1)         The registrant shall comply with the requirements of 32 Ill. Adm. Code 320 and 340; 2)         The registrant shall not permit any individual to operate a cabinet x-ray system until the individual has been instructed in the operating and emergency procedures for the unit and has demonstrated, to the satisfaction of the registrant, competence in its use; 3)         Each cabinet x-ray system shall be manufactured and assembled in conformance with the regulations in 21 CFR 1020.40, published April 1, 2002, exclusive of subsequent amendments or editions; 4)         The registrant shall maintain for review  by the Agency information regarding the operating parameters and workload of each cabinet system; and 5)         Tests for proper operation of interlocks installed in accordance with 21 CFR 1020.40 shall be conducted and recorded in accordance with Section 350.1090 of this Part.